Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Worldwide Distribution - USA (nationwide)
Symbiq Two Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids  Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and 16027. When there are false alarms, the pump will continue to alarm even though there is no occlusion present. False POAs could result in a delay/interruption in therapy, and require the clinician to reset the alarm multiple times or to replace the pump.
Symbiq One Channel Infuser; an Rx medical device infusion pump used to administer I.V. fluids  Device is a general purpose infusion pump designed to deliver fluids, solutions, medications, agents, nutritionals, electrolytes, blood and blood products for parenteral administration; and various solution through enteral, intravenous, intra-arterial, subcutaneous, and pathways.
*** 1) Product labeled in part: 14951-48; LIFESHIELD; PLUMSET WITH CONVERTIBLE PIERCING PIN, TWO INTEGRAL CLAVE PORTS AND CLAVE ON SECONDARY PORT; NOMINAL LENGTH: 104 IN (264 CM); PRIMING VOLUME: 19 ML;   *** 2) Product labeled in part: 14952-01; LIFESHIELD; HEMA Y-TYPE BLOOD PLUMSET, NONVENTED WITH 210 MICRON FILTER AND OPTION-LOK, DUAL CHANNEL, CLAVE SECONDARY PORT; NOMINAL LENGTH: 102 IN (260 CM); PRIMING VOLUME: 69 ML;    *** 3) Product labeled in part: 14954-28; LIFESHIELD; LIFECARE 5000 WITH PROXIMAL 0.2 MICRON FILTER-0L, CONVERTIBLE PIN, DUAL CHANNEL, INTEGRAL Y CLAVE, NON-DEHP; NOMINAL LENGTH: 112 IN (284 CM); PRIMING VOLUME: 24 ML; ***   4) Product labeled in part: List No. 19553-12; LifeShield; LATEX-FREE; PLUM EXTENSION SET WITH CLAVE SECONDARY PORT; NOMINAL LENGTH: 28 IN (71 CM); PRIMING VOLUME: 7.1 ML; SET CONTAINS DEHP;   *** 5) Product labeled in part: 19556-28; LIFESHIELD; PLUMSET HEMOSET 100 ML BURETTE, DUAL CHANNEL CASSETTE WITH CLAVE, SECURE LOCK, NON-DEHP NOMINAL LENGTH: 98 IN (249 CM); PRIMING VOLUME: 17 ML; *** 6) Product labeled in part: 19557-28; LIFESHIELD; PLUMSET CONVERTIBLE PIN, TWO INTEGRAL CLAVES, CLAVE SECONDARY PORT AND OPTION LOK, NON-DEHP; NOMINAL LENGTH: 110 IN (279 CM); PRIMING VOLUME: 21.4 ML;   *** 7) Product labeled in part: 19671-28; LIFESHIELD; CONVERTIBLE PP LIFECARE 5000 CASSETTE W/CLAVE MICRODRIP SOLUSET 150 X 60 DPM, CLAVE INJECTION SITE, NON DEHP; NOMINAL LENGTH: 124 IN (315 CM); PRIMING VOLUME: 13 ML;   *** 8) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML;   *** 9) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML; USA;   *** 10) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3
Intravenous fluid may leak at the CLAVE secondary port of Hospira PlumSet IV administration sets.
*** 1) Product labeled in part: List No. 14220-28; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, CLAVE Y-Site, Non-Vented, 110 Inch, Non-DEHP; Product  Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
***** CANADA DISTRIBUTION *****     *** 1) List Number 14220-28-01
*** 1) Product labeled in part: 19683-28; LIFESHIELD; MICRODRIP SOLUSET WITH 1.2 MICRON FILTER 150ML BURETTE PLUMSET, CONVERTIBLE PIN, CLAVE SECONDARY PORT, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 118 IN; PRIMING VOLUME: 14 ML;   *** 2) Product labeled in part: List No. 19685-28; LifeShield; LATEX-FREE; PLUMSET, PRIMARY CONVERTIBLE PP W/ SIGHT CHAMBER, THREE WAY STOPCOCK, CLAVE INJECTION PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 136 IN (345 CM); PRIMING VOLUME: 24 ML;    *** 3) Product labeled in part: 19720-28; LIFESHIELD; PLUM SET, CONV P.P, DUAL CHANNEL 3 CLAVE PORTS,IN LINE CHECK VAL OPTION LOK, NON-DEHP.; NOMINAL LENGTH:145 IN (368 CM); PRIMING VOLUME:13 ML;  *** 4) Product labeled in part: 19721-28; LIFESHIELD; SOLUSET 150ML BUR,CONV P.P DUAL CHANNEL 4 CLAVE PORTS IN LINE CHECK VAL OPTION LOK, NON-DEHP; NOMINAL LENGTH: 145 IN (368 CM); PRIMING VOLUME: 15 ML:   *** 5) Product labeled in part: 19729-28; LIFESHIELD; CONV. DUAL CHANNEL PLUMSET WITH CLAVES, AND SECURE LOK, NON-DEHP; NOMINAL LENGTH: 96 IN (244 CM); PRIMING VOLUME: 18 ML;   *** 6) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML;     Product Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
*** 1) Product labeled in part: 19734-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET, MICRODRIP,PP SOLUSET,FILTER, 3 CLAVE PORTS, OPTION-LOK, NON-DEHP; NOMINAL LENGTH: 124 IN (315 IN); PRIMING VOLUME: 14 ML; *** 2) Product labeled in part: 19732-28; LIFESHIELD; LIFESHIELD LATEX-FREE PLUM SET,MICRODRIP,PP CHECK VALVE AND CLAVE OPTION-LOK, NON-DEHP; NOMINAL LENGTH:104 IN (264 CM); PRIMING VOLUME: 13 ML;  Product  Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
*** 1) Product labeled in part: List No. 14212-28; LIFESHIELD; PLUM Y-TYPE BLOOD SET; 200 Micron Filter, CLAVE Port, Non-Vented, 110 Inch, Non-DEHP; *** 2) Product labeled in part: List No. 14254-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port 2 CLAVE Y-Sites, 0.2 Micron Filter, 112 Inch, Non-DEHP;   *** 3) Product labeled in part: List No. 14687-28; LIFESHIELD; PRIMARY PLUMSET; CLAVE Port, CLAVE Y-Site; 103 Inch, Non-DEHP;   Product  Usage:  The CLAVE of the secondary port is used as an easy secondary access that allows concurrent and piggyback mode in infusion. It is normally used with a syringe or a secondary IV infusion set.
sold to distributors and manufacturers. See attached.
Freeze dried banana 1/4 diced packaged in 20 lb. containers with white label and black lettering.
2, 560 lbs. distributed in bulk 20 lb. container.
Customer received a 1,000g sample of freeze dried bananas, had it tested at 3rd party lab and received a positive test result for Salmonella.
65 cases were used for sales samples and gifts.  Of those cases (520 cartons) ~ 20 cartons are not accounted for and were most likely given to employees and or consumed.  17 other cases were used by Marketing and R&D.
Margaritaville 4.16 ounce packages of Banana creme pie filling mix packaged in a yellow, red, and blue box with white lettering.
There was a positive salmonella sample from another customer of the supplier that tested it. This firm uses the freeze dried bananas in their Banana creme pie filling mix.
Lot Code: WC5257    Best before Sept 2017   Universal Product Code: 7239202925
Product was distributed Nationwide.  There was no military, government, or foreign distribution.
Maytag Blue Cheese. Wedges and wheels are packaged in an aluminum foil wrapper and shipped in cardboard box. The wedges and wheels are packaged in the following sizes:     1) 4 LB. wheel, UPC 8 54089 00114 0;  2) 2 LB. wheel, UPC 8 54089 00112 6;  3) 1 oz. wedges, UPC 8 54089 00102 7;  4) 4 oz. wedges, UPC 8 54089 00104 1;  5) 8 oz. wedges, UPC  8 54089 00108 9;     Maytag Blue Cheese Crumbles are packaged in    6) 8 oz. plastic cups (UPC 8 54089 00183 6);  7) 5lb.bulk box (UPC 8 64089 00181 2)    The responsible name of the label and shipping box is Maytag Dairy Farms, Newton, IA 50208.
Product is contaminated with Listeria monocytogenes.
Worldwide Distribution - US including AL, AR, AZ, CA, CO, CT, FL, GA, IL, KY, LA, MA, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, PR, SC, TN, TX, UT, VA, VT, WA, WI, WV and Internationally to Canada.
Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vials, Rx Only, NDC 0487-9007-60.  A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the vial.
Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vials per carton, Rx Only,  NDC 0487-9003-60.  A vial contains sterile, preservation-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. For respiratory therapy, Solium Chloride Inhalation Solution USP, 3% is used in conjunction with a nebulizer
US Nationwide in the states of AL, AR, FL, GA, MA, NC, NY, NJ, NH, PA, OH, TX & VA; International:  Canada
dynarex Specimen Containers, Screw-On, Leak-Resistant Lid, Tamper-Evident Seal, Sterile, Single Use Only    Product Usage:containers for sample collection
399 cases/25 sleeves/20 cups & lids per sleeve
Exterior carton is mis-labeled as Sterile.  Non-sterile, bulk specimen containers were packed in incorrect exterior carton.
US Distribution to the states of: CA, IN, MI, NY, PA, TX & VA
The seal between the balloon and the housing may leak.
Worldwide Distribution - US including CA, MI, LA, OH, NY, IN, WA; Internationally: to CA
IMPAK Liquid Acrylic Resin sold under the following labels:  1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314  2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325 cc), Part No. 3748  3) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, 1 Quart (946 cc), P/N 3306  4) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid PN 7450,   5) ThermoFlex ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS 1 Quart (946 cc) P/N 7465  Indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base
236 pieces (25 pieces/11 oz, 211 pieces/1 Quart)
Possible presence of foreign material (rust).
Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only, a) 2.5 mL Bottle, b) 5 mL Bottle, c) 10 mL Bottle, For Topical Ophthalmic Use Only, Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701, NDC: a) 50383-0282-02, b) 50383-282-05, c) 50383-0282-10
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
distributed in AL, AR, AZ, CA, CO, HI, ID, IL, IN, KS, KY, MI, MN, MO, MT, NC, NE, NM, NV, OH, OK, OR, PA, SD, TN, TX, UT, WA, WI, WY, and British Columbia.
Safeway Classic Potato Salad, Refrigerated, Retail package, net wt. 5.5oz.  UPC 0 21130 06716 9.
Safeway Classic Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Safeway Tuna Salad, Refrigerated, Retail package, Net wt. 15 oz.   UPC 021130 06742  8.    Safeway Tuna Salad, Refrigerated, Foodservice package, net wt. 3 lbs.   UPC 0 71117 06036 2.
Safeway Tuna Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Stonemill Kitchens Classic Potato Salad, Refrigerated, Retail net wt. 5lb.  UPC 0 71117 61576 0.
Stonemill Kitchens Classic Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Reser's Macaroni Salad, Refrigerated, Retail package, Net Wt. 8 oz.   UPC  0 71117 18224 8.    Reser's Macaroni Salad, Refrigerated, Retail package, Net Wt. 16 oz.  UPC 0 71117 19007 6.    Reser's Macaroni Salad, Refrigerated, Retail package, Net Wt. 3 lb.  UPC 0 71117 19305 3.    Sysco Elbow Macaroni Salad, Refrigerated, Food Service package, Net wt. 8 lb. UPC 71117 67702
Macaroni Refrigerated Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Reser's brand, Net Wt. 8 oz packages have the Use By Date: 5/10/2016;  Reser's brand,Net Wt. 16 oz packages have the Use By Date: 5/9/2016;  Reser's brand,Net Wt. 3 lb. packages have the Use By Dates: 5/9/2016 and 5/10/2016;  Sysco brand - food service packages have the Use By Date: 5/7/2016.
Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 3.5 oz.   UPC 0 71117 17000 9.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 5.5 oz.   UPC 0 71117 17100 6.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 8 oz.   UPC 0 71117 18223 1.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 16 oz.   UPC 0 71117 19000 7.    Reser's Original Potato Salad, Refrigerated, Retail package, Net wt. 3 lb.   UPC 0 71117 19300 8.    Food Service of America (FSA) Potota Salad, Refrigerated, Foodservice package, Net wt. 8 lb. UPC 0 41493 41720 3.
Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Reser's brand, Net wt. 3.5 oz, 5.5 oz,  and 16 oz, retail packages have the Use By Date: 05/10/2016;    Reser's brand, Net wt. 8 oz and 3 lb., retail packages have the Use By Date: 5/9/2016;    FSA, net wt. 8 lbs., Foodservice packages have the Use By Date: 5/10/2016.
Walmart Redskin Potato Salad, Refrigerated, Retail net wt. 4lb.   UPC 81131 91693 6.
Walmart Redskin Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Reser's Deviled Egg Potato Salad, Refrigerated, Retail package, Net wt. 3 lbs. UPC 0 71117 00480 9;    Reser's Deviled Egg Potato Salad, Refrigerated, Foodservice product, net wt. 8 lbs. UPC  71117 00225;    Safeway Deviled Egg Potato Salad, Refrigerated, Net wt. 16 oz.   UPC 0 21130 06688 9.
Deviled Egg Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Reser's brand- Retail packages have the Use by Date: 04/29/2016;  Reser's brand- 8 lb. Foodservice packages have the Use by Date: 4/28/2016;  Safeway brand has the Used by Date: 4/28/2016;
Savemart Potato Salad, Refrigerated, Foodservice package, Net wt. 8 lbs.  UPC 71117 00443
Savemart Potato Salad is recalled due to a potential to be contaminated with Listeria monocytogenes.   This product was made with one lot of onion which was recalled by supplier.
Lisinopril Tablets, USP 30mg, packaged in a) 500 count bottles, and b)100-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-516-02, b) 68180-516-01
CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.
Lisinopril & Hydrochlorothiazide Tables, USP 20mg/12.5mg, packaged in a)100-count bottles and b) 5000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, a) NDC 68180-519-01, b) 68180-519-30
Lisinopril Tables, USP 40 mg, 1000-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 India, NDC 68180-517-03
R    No Sugar Added;  Dark Chocolate  34 g/1.2 oz.  Ross Chocolates, 4061 Butters Road, Scotch Creek, BC  UPC 726007100054  Best Before: 191018
Manufacturer Ross Chocolates, Coquitlam, BC Canada recalled these chocolate bars as the new labels failed to declare the possible milk allergen.
Worldwide Distribution - US (Nation Wide) including Puerto Rico and Internationally to Denmark, Guam
Naso-Pharyngo-Laryngoscope  Intended to provide optical visualization of, therapeutic access to, the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Ear, Nasal Passage and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations
Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel.
Model #'s FNL-10RAP, FNL-13RAP, FNL-15RP3 and VNL-1530T
Small Bowel Scope  Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Cystoscope  Intended to provide optical visualization of and therapeutic access to the Urinary Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Urethra to the Bladder. The instrument is introduced via the urethra when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Model #'s ECY-1530, ECY-1570K, FCY-15P2 and FCY-15RBS
Colonoscope  Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Cecum. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Ultrasound Gastroscope  Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Upper Gastrointestinal Track including but not restricted to organs, tissues and subsystems: Esophagus, Stomach, Duodenum, Small Bowel and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric
Model #'s EG-3630U, EG-3630UR, EG-3670URK, EG-3830UT, EG-3870UTK, FG-34UX, FG-36UX and FG-38UX
Esophagoscope  Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Signmoidoscope  Intended to provide optical visualization of, therapeutic access to, the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Large Bowel to the Sigmoid Colon. The instrument is introduced via the rectum when indications consistent with the need for procedure are observed in adult and pediatric patient populations
Ureteroscope  Intended to provide optical visualization of and therapeutic access to the Urinary Track. This anatomy includes but is not restricted to the organs, tissues and subsystems: Urethra, Bladder and Renal Pelvis. The instrument is introduced via the urethra when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations.
Confocal GI Scope  Intended to provide optical visualization of an therapeutic access to the Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum, and Large Bowel to the Cecum. The instrument is introduced via the mouth or rectum as decided by the anatomy being accessed when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Ultrasound Bronchoscope  Intended to provide optical visualization of, ultrasonic visualization of and therapeutic access to, the Pulmonary Tract including but not restricted to organs, tissues and subsystems: Nasal Passage, Pharynx, Larynx, Trachea, Bronchial Tree (including access beyond the stem), and underlying areas. The instrument is introduced orally when indications consistent with the requirement for procedure are observed in adult and pediatric patient populations
Laryngo Stroboscope  Product Usage	Intended to provide optical visualization of, therapeutic access to, the Upper Airway and Vocal Folds. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx, Pharynx and Vocal Cords. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Intubation Scope  Intended to provide optical visualization of, therapeutic access to, and use to facilitate routine or difficult tracheal intubations of the Upper Airway. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Larynx and Trachea. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Model #'s FI-10BS, FI-10P2, FI-10RBS, FI-13BS, FI-13P, FI-13RBS, FI-16BS, FI-16RBS, FI-9BS and FI-9RBS
Gastroscope  Intended to provide optical visualization of and therapeutic access to the Upper Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Esophagus, Stomach and Duodenum. The instrument is introduced via the mouth when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Choledocho-Nephroscope  Intended to provide optical visualization of and therapeutic access to the Abdominal Cavity. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Biliary tree with access to the Common bile Duct, Hepatic Duct, Cystic Duct, Kidney, Renal Cavity and Renal Calyces. The instrument is introduced via percutaneous cut when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Choledochoscope  Intended to provide optical visualization of and therapeutic access to the Biliary Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Common Bile, Hepatic, Cystic and Pancreatic Ducts. The instrument is introduced via the working channel of a Duodenoscope positioned for access to the Common bile Duct when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Bronchoscope  Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trachea and Bronchial Tree. The instrument is introduced via the mouth or the nose, as decided by the physician, when indications consistent with the need for procedure are observed in adult and pediatric patient populations.
Universal Quick Adjust under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, tall adult, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.
Tip crutch failure involving the bottom of the metal portion which comes in contact with ground
Aluminum crutch under the following labels: 1) Aluminum crutch, adult, 1 pair per case, 2) Aluminum crutch, adult, 8 pairs per case, 3) Aluminum crutch, youth, 1 pair per case, 4) Aluminum crutch 8 pairs per case, 5) Aluminum crutch, tall adult, 1 pair per case & 6) Aluminum crutch, tall adult, 8 pairs per case
EZ adjust aluminum crutch under the following labels: 1) EZ adjust aluminum crutch, adult, 1 pair per case, 2) EZ adjust aluminum crutch, adult, 8 pairs per case, 3) EZ adjust aluminum crutch, youth, 1 pair per case, 4) EZ adjust aluminum crutch, youth, 8 pairs per case, 5) EZ adjust aluminum crutch, tall adult, 1 pair per case & 6) EZ adjust aluminum crutch, tall adult, 8 pairs per case
Direct Supply aluminum crutch, adult, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.
Universal aluminum crutch, 1 pair per case    Aid the user in walking while relieving weight from one foot or leg.
Eban Bakery Gluten Free Breads and Baked Goods LLC
.  The cookies are packaged 6 per container. The container is a plastic tub with lid and tamper proof band.
Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 11 oz (325 ML), REF 3748, Rx ONLY, 3) BRUX-EZE AN ELASTIC ACRYLIC RESIN FOR THE CONSTRUCTION OF DENTAL TREATMENT APPLIANCES, 1 Quart Liquid, PN 7450;  Indicated for relining a denture surface.
Lot Number: 79943  Expiration Date: March 2021
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
Pita Pal Mediterranean Three Bean Net Wt. 8 oz. (226g) UPC: 8-50157-0007-7 Keep Refrigerated Pita Pal Foods, LP Houston, TX 7003 www.pitapal.com; Pita Pal Mediterranean Three Bean Salad UPC: 8-50157-00048-0 Keep Refrigerated Net Wt: 24 oz.; Pita Pal Mediterranean Three Bean Salad UPC: 8-50157-00084-8 Keep Refrigerated Net Weight: 4 lbs
Product may be contaminated with Listeria monocytogenes.
Expiration Date or Use/Freeze by dates through June 13, 2016.
Pita Pal Chipotle Quinoa & Black Beans Superfood Mild Net Wt 28 oz (1.75 LBS) 793g Keep Refrigerated UPC: 8-50157-00017-6 www.pitapal.com Pita Pal Foods, LP. Houston, TX 7703
Hightower Corn Relish UPC: 8-51570-00386-7 5 pound plastic containers Manufactured By Pita Pal Foods Keep Refrigerated
Pita Pal Texas Caviar Net Wt. 8 oz. (226g) UPC: 8-50157-0006-0 Keep Refrigerated Pita Pal Foods, LP. Houston, TX 77003 www.pitapal.com; Pita Pal Texas Caviar UPC: 8-50157-00086-2 Keep Refrigerated Net Weight: 4.5 lbs;
Benzphetamine Hydrochloride Tablets, 50 mg, 30-count bottle, RX only, Mfd by: KVK-TECH, INC., Newtown, PA 18940, NDC 10702-0040-03
9360 bottles of lot # 12825A and 7284 bottles of lot # 12937A
Discoloration: presence of scuffing marks on tablets.
Product was shipped to the following states: AK, AL, AR, AZ, CA, CO, GA, ID, IL, IN, KS, KY, LA, MI, MO, MS, MT, NC, NE, NM, NV, OH, OR, SC, TN, TX, UT, VA, WA, WV & WY.
simple truth organic Mixed Vegetables NET WT 10 OZ (283g) KEEP FROZEN INGREDIENTS: ORGANIC CARROTS, ORGANIC CORN ORGANIC PEAS, GREEN BEANS.
The firm was notified by their supplier that the product maybe contaminated with Listeria monocytogenes.
Piggly Wiggly, Yellow Cut Corn, Net Wt 32oz (2 lbs), 907g bags, Distributed by Piggly Wiggly LLC, Keene, NH 03431.
Distributed US (nationwide) and in Canada.
Alaris System PC Unit Model 8015 with software versions 9.17 and 9.19;  Central programming, monitoring and power supply component for the Alaris System.
A patient weight can be populated incorrectly under certain conditions when using the RESTORE feature to restore infusions running on the Alaris LVP module model 8100 and the Alaris Syringe module model 8110.
aloe SPORT liniment TOPICAL ANALGESIC 8 fl oz. tube, ALOE VERA  Liniment Topical Analgesic 8 fl oz. bottle, Manufactured by Coats International, Inc.,  the ALOE SOURCE SPORT Sport Thermogenic Eucalyptus Cream 1 fl oz. plastic bottle, Dallas, TX 75243, NDC 58826-704-08, UPC 732295704089
577 (212 1 fl oz.. plastic bottles, 167 8 fl oz. plastic bottles, 198 8 fl oz. plastic tubes)
Productos Del Campo Castillo Chile Habanero (Fresh Habanero Peppers)
154 boxes each containing 8 lbs of product  for a total of 1,232 lbs.
Potential to be contaminated with Salmonella.
Lot Number 41142 and Lot Number 41143 is printed on top of the cartons of recalled products
Cadence Size 5 Left Tibial Tray Implant, designed to treat ankle arthritis through replacement of the ankle joint with a prosthesis, thereby reducing pain, restoring alignment, and allowing for movement at the replaced joint. Catalog Number: 10207205; Lot Number #QJ0248
As a result of an internal review of all labeling for the Cadence System, it was determined that the outer package label for the Size 5 Left Tibial Tray Implant reflects the material composition incorrectly.  The labeling incorrectly reflects the material as Cobalt Chromium instead of Titanium.
Worldwide Distribution-US (nationwide) including Guam and Puerto Rico and countries of: Argentina, Austria, Australia, Bahamas, Bangladesh, Belgium, Brazil, Brunei Darussalami, Canada, Chile, China, Croatia, Cyprus. Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Kenya, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Singapore,  Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan (Province of China), Turkey, United Arab Emirates, United Kingdom, New Caledonia, and New Zealand,.
LIFEPAK CR Plus and/or LIFEPAK EXPRESS are Automatic External Defibrillator(s) and are non-wearable.    LIFEPAK CR Plus and LIFEPAK EXPRESS defibrillators are intended for use on patients in cardiac arrest.
25178 units (10,418 in US and 14,760 outside US)
LIFEPAK CR Plus Automated External Defibrillators (AED) or LIFEPAK EXPRESS AED may fail to initiate voice prompts when the ON/OFF button is pressed and the lid is opened due to an internal component (reed switch) that can intermittently become fixed in the closed position. A defibrillator in this condition will fail to deliver a shock, with the potential result that therapy is not delivered and a patient is not resuscitated.
CVS pharmacy Original Strength Acid Controller tablets, 10 mg, 30-count bottle, OTC,  Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, UPC 150049523
Failed impurities/degradation specification: An out of specification results has been determined for an individual related substance during stability testing at the 18th month interval for the Famotidine 10 mg Tablet, USP.
Nationwide Distribution to OK, CA, TX, WA, GA, NY, MS, NY, PA
K-wire, Smooth Double-pointed 0.8 x 90mm, a component of the METASURG Capture Screw System   The K-wire is used in conjunction with the 2.0 mm cannulated screws for the METASURG Capture Screw System. The K-wire is used by the physician to insert into the bone and to act as a guide for drilling, countersinking and installing screws
The affected K-wires do not meet specification requirements. Specifically, a) K-wires were made of 316LVM stainless steel instead of 304 stainless steel. b) K-wires have passivated surface finish instead of electro-polish surface finish. c) K-wires have incorrect length and diameter.
Distributed to Columbia and the following US states: AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KY, MA, MD, MI, MN, MO, MS, NC, ND, NE, NJ, NV, NY, OH, OR, PA, TN, TX, UT, VA, WA, WI
PrismaSate BGK2/0 Dialysis Solution for Continuous Renal Replacement Therapy
Presence of leaks near top of the PrismaSate bags
Liquid stable 2 part Homocysteine Reagent, for in vitro quantitative determination of total homocysteine in human serum and plasma - H7575-57 kit includes one Rl and one R2 bottle and one bottle of calibrator level 1 and one bottle of calibrator level 2.
Deterioration in performance of the Liquid Stable (LS) 2-Part HOMOCYSTEINE REAGENT resulting in under recovery.  The manufacturer has indicated that the HOMOCYSTEINE REAGENT lot listed above shows deterioration in assay performance manifesting itself by under recovery of Homocysteine in Controls and Patient Samples.  The cause of this deterioration has been attributed to a loss of reductant activity in Reagent 1.  Testing performed indicated that the affected lot is at the limit of acceptable clinical performance. This observation was consistent across the reportable range of the assay. For this reason, do not continue to use affected reagent lot. Test data generated to date will be acceptable where validity control specifiCations have been met.
Model: H7575-57  Lot: 416703  Expiration date: 2016-01
Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.
The surface inside of the femoral component, where cement is applied for adhesion, is below specification.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.
LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375    The LEGION Hinge Knee System is indicated for:  1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery.  The LEGION Hinge Knee System is for cemented use only.
Medtronic Sofamor Danek Usa, Inc - Dallas Distribution
Worldwide Distribution-Including the states of AL, AR, AZ, CA, CT, FL, GA, IA, ID, IL, IN, MA, MD, NC, NH, NY, SC, TN, TX, and UT.
Saw Sagittal Catalog Number: ES 300; Saw Sagittal Refurbished Catalog Number: ES300-R; Saw Saggital, Finger Catalog Number: ES310; Saw Saggital, Finger Refurbished Catalog Number: ES310-R; Used to dissect bone in surgical applications.
Medtronic Powered Surgical Solutions testing of the Sagittal Saw Rocker Arm Seal identified a potential for leakage of fluid into the motor during use.
Nationwide: AL, AR, AZ, CA, CO, CT, FL, GA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NJ, NM, NV, NY, OH, OK, PA, SC, SD, TN, TX, VA, WA, WI, WV.
Hettich Centrifuge Modules:  StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836)  Aptio Centrifuge Module (10703032 or 10713761)  FlexLab High Throughput Centrifuge Module (11171747)  FlexLab and Aptio Centrifuge Module (10628157 or 11266581): Used to separate substances according to their densities.
The grounding pin within the Power Entry Switch on certain systems was susceptible to detachment when the AC power cable is removed.
Ciprofloxacin OPTH 0.3%  SOL, generic for: Ciloxan, Rx Only,  2.5 mL Bottle, Repackaged by: Aidarex Pharmaceuticals, MFG: Hi-Tech Pharmacal Co., Inc., Amityville, NY, 11701, NDC a) 33261-0910-01, b) 33261-0614-01
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Bayou Brothers Creole Sauce NET WT 33OZ. (2 LBS 1 OZ) 936g packaged in a glass jar
Apheresis Platelets, Leukocytes Reduced, Irradiated
Platelet products, labeled as leukoreduced but were not tested for WBCs, were distributed.
American National Red Cross, Penn Jersey Region
Blood product, collected from a donor for whom eligibility was inadequately determined, was distributed.
US Distribution including Puerto Rico and to the states of : AK, AZ, CA, FL, GA, IL, IN, LA, MD, MI, MO, NJ, NY, OH, OR, PA, TN, TX, UT, VA, WA, and to the countries of :  Canada, Denmark, Finland, Germany, Israel, Japan, Netherlands, Norway, Sweden, United Kingdom
It is possible that that the selected Plan-of-the Day could be accidently changed by scrolling the mouse wheel up and down and inadvertently selecting another plan.
US Distribution to the states of : AL, CA, CT, FL, IN, KS, LA, MA, MD,  MI, MN, MO, MS, NE, NY, OH, OR, PA, TX, WI
Syngo.plaza, Picture archiving and communication system (PACS), Model Numbers - 10863171, 10863172, 10863173,
Software error in previous software versions in which two references for the same image may exist in the database.
Worldwide Distribution - US Distribution and to the countries of : Algeria, Australia, Austria, Bangladesh, Belgium, Bolivia, Bosnia and Herzegovina, Botswana, Brazil, Brunei Darussalam, Bulgaria, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Djibouti, Ecuador, Egypt, El Salvador, Estonia, France, Germany, Ghana, Gibraltar, Greece, Guam, Honduras, Hong Kong, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kenya, Kuwait, Lebanon, Lithuania, Macao, Malaysia, Mayotte, Mexico, Morocco, Namibia, Netherlands, New Zealand, Nigeria, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Serbia, Sierra Leone, Singapore, Slovakia, South Africa, Spain, Swaziland, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom,  Uruguay, Venezuela, Viet Nam, Zambia, Zimbabwe
Access Free T3 Assay, Ref No. A13422    The Access Free T3 assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of free triiodothyronine levels in human serum and plasma using the Access Immunoassay Systems.
Demonstrate an upward shift in patient results.
Worldwide Distribution - US Nationwide in the states of: PA, CA, AL, NC and countries of Austria, Bosnia and Herzegovina, Belgium, Bulgaria, Brazil, Canada, Switzerland, Germany, Spain, France, Greece, Italy, Macedonia,  Qatar, Romania, Serbia, Sweden, and Turkey.
An incorrect HER2 probe concentration was used when producing the probe component (Vial 3) in this kit lot. This has resulted in the HER2 probe concentration being too low.
SYNGO Breast Care,  visualization and image enhancement tools to aid radiologist in the review of digital Mammography images and tomosynthesis datasets.
US Nationwide Distribution in the states of CA, FL, ID, KS, MI, NY,OH,TX
Brilliance 64, Computed Tomography X-ray system    Product Usage:  The Brilliance CT 64 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Philips Healthcare received reports from the field that certain Brilliance 64 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images.  A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Ingenuity Core-Computed Tomography X-ray system    Product Usage:  The Ingenuity Core scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Philips Healthcare received reports from the field that certain Ingenuity Core systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images.  A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Ingenuity Core 128-Computed Tomography X-ray system    Product Usage:  The Ingenuity Core 128 scanner is a whole body Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes..
Philips Healthcare received reports from the field that certain Ingenuity Core128 systems running software version 3.5.4 exhibited intermittent swirl-like ring artifacts that may appear on reconstructed images.  A patient rescan may be required if the images cannot be used for interpretation due to the swirl-like artifact.
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
Blood and Blood Products for Reprocessing
Blood product, for which donor suitability was inadequately determined, was distributed.
Blood product, collected from a donor who tested positive for the antibody to Hepatitis B core Antigen on more than one occasion, was distributed.
Pooled Cryoprecipitated AHF products, identified as unsuitable due to a component preparation deviation, were distributed.
Plasma product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
Blood product, collected from a donor who was not deferred after testing reactive for anti-HTLV, was distributed.
ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box.  For use with CSI Peripheral Orbital Atherectomy Devices (OAD), including Stealth 360 and Diamondback 360.  Cardiovascular.
The pouch label was missing the use by date (UBD) of 2018-04.
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
U.S. distribution to the following; OH, IL, NY, MD, MA, CA.    Foreign distribution to the following; Japan and Israel.
HLA test kits, which may be associated with false negative reactions, were distributed.
Worldwide distribution to Belgium, China, Egypt, Germany, India, Korea, Republic of, Myanmar, Nigeria, Peru, Russian Federation, Rwanda, Singapore, Spain, Sweden, Taiwan, Thailand, and United Kingdom
Big Bore Oncology tomography X-ray system scanner, model number 728243.   The Big Bore Oncology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes
Socket Head Cap Screws (SHCS) used in the Z-Axis Adjustment Plate were found to be made of stainless steel rather than the specified alloy steel.
Big Bore Radiology tomography X-ray system scanner, model number 728244.   The Big Bore Radiology scanner is a whole body computed tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes.
Big Bore Radiology System Code 728244; Serial numbers  75033, 75110
Distributed in China, Denmark, Germany, Hungary, Italy, Philippines, Spain, Sweden, Switzerland, Thailand, and United Kingdom.
Brilliance iCT model #728306; Intended to produce cross- sectional  images of the body.
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack.
Ingenuity Core, model # 728326; Intended to produce cross- sectional  images of the body.
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack causing injury to patients, operators, by-standers and service personnel.
Brilliance CT Big Bore Oncology, model #728243; Intended to produce cross- sectional  images of the body.
Supplier design change contributed to a thinner plastic which was used as part of the cover on the devices. The thinner plastic cover may crack and cause injury to patients, operators, by standers or service personnel.
Ingenuity Flex, model # 728317; Intended to produce cross- sectional  images of the body.
Ingenuity Core 128, model #728323; Intended to produce cross- sectional  images of the body.
Valeant Pharmaceuticals North America LLC
SECONAL SODIUM (secobarbital sodium) Capsules, USP, 100 mg, 100 Ct. Bottles, Rx Only. Distributed by: Valeant Pharmaceuticals North America, LLC, Bridgewater, NJ 08807. NDC: 0187-4220-10.
Labeling: Incorrect or Missing Package Insert: Package insert is missing warning regarding anaphylaxis.
Brilliant Blue G BBG, 0.025%, Sterile Injection, 0.5 mL Single Dose Vial, Vital Care Compounder, Hattiesburg, MS
Lack of Assurance of Sterility:  Aluminum crimps do not fully seal the rubber stopper to the vials.
Trypan Blue 0.3%, 0.5 mL Vial, Vital Care Compounder, Hattiesburg, MS
Methylcobalamin 5,000 mcg/ml, Sodium Chloride 0.9%,1 mL SDV, Vital Care Compounder, Hattiesburg, MS